Overcoming barriers to improved decision-making for battery deployment in the clean energy transition.

Decarbonization plans depend on the rapid, large-scale deployment of batteries to sufficiently decarbonize the electricity system and on-road transport. This can take many forms, shaped by technology, materials, and supply chain selection, which will have local and global environmental and social impacts. Current knowledge gaps limit the ability of decision-makers to make choices in facilitating battery deployment that minimizes or avoids unintended environmental and social consequences. These gaps include a lack of harmonized, accessible, and up-to-date data on manufacturing and supply chains and shortcomings within sustainability and social impact assessment methods, resulting in uncertainty that limits incorporation of research into policy making. These gaps can lead to unintended detrimental effects of large-scale battery deployment. To support decarbonization goals while minimizing negative environmental and social impacts, we elucidate current barriers to tracking how decision-making for large-scale battery deployment translates to environmental and social impacts and recommend steps to overcome them.

Multi-Strategy Assessment of Different Uses of QSAR under REACH Analysis of Alternatives to Advance Information Transparency.

Under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) analysis of alternatives (AoA) process, quantitative structure-activity relationship (QSAR) models play an important role in expanding information gathering and organizing frameworks. Increasingly recognized as an alternative to testing under registration. QSARs have become a relevant tool in bridging data gaps and supporting weight of evidence (WoE) when assessing alternative substances. Additionally, QSARs are growing in importance in integrated testing strategies (ITS). For example, the REACH ITS framework for specific endpoints directs registrants to consider non-testing results, including QSAR predictions, when deciding if further animal testing is needed. Despite the raised profile of QSARs in these frameworks, a gap exists in the evaluation of QSAR use and QSAR documentation under authorization. An assessment of the different uses (e.g., WoE and ITS) in which QSAR predictions play a role in evidence gathering and organizing remains unaddressed for AoA. This study approached the disparity in information for QSAR predictions by conducting a substantive review of 24 AoA through May 2017, which contained higher-tier endpoints under REACH. Understanding the manner in which applicants manage QSAR prediction information in AoA and assessing their potential within ITS will be valuable in promoting regulatory use of QSARs and building out future platforms in the face of rapidly evolving technology while advancing information transparency.

Nanotechnology for a Sustainable Future: Addressing Global Challenges with the International Network4Sustainable Nanotechnology.

Nanotechnology has important roles to play in international efforts in sustainability. We discuss how current and future capabilities in nanotechnology align with and support the United Nations' Sustainable Development Goals. We argue that, as a field, we can accelerate the progress toward these goals both directly through technological solutions and through our special interdisciplinary skills in communication and tackling difficult challenges. We discuss the roles of targeting solutions, technology translation, the circular economy, and a number of examples from national efforts around the world in reaching these goals. We have formed a network of leading nanocenters to address these challenges globally and seek to recruit others to join us.

Evaluating the Application of Decision Analysis Methods in Simulated Alternatives Assessment Case Studies: Potential Benefits and Challenges of Using MCDA.

We compare how several forms of multicriteria decision analysis (MCDA) can enhance the practice of alternatives assessment (AA). We report on a workshop in which 12 practitioners from US corporations, government agencies, NGOs, and consulting organizations applied different MCDA techniques to 3 AA case studies to understand how they improved the decision process. Participants were asked to select a preferred alternative in each case using a different decision analysis approach: their unaided decision-making method, individual or lightly facilitated group multiattribute value theory (MAVT), and more extensively facilitated group structured decision making (SDM). Surveys conducted after each exercise revealed that participants were positive toward the use of formal decision-making methods for AA, reporting meaningful increases in their understanding of the trade-offs involved and their own values. Participants also reported challenges with each approach. While the MCDA techniques were reported to enhance transparency and communication, they did not consistently lead to higher satisfaction with a decision and/or outcome, and they were not more likely to be adopted within their organizations than unaided approaches. More formal decision-making methods have promise in the context of AA, but practitioners will need more guidance to use such tools successfully. Practitioners will also need to define what "success" constitutes; different approaches may be called for depending on whether the objective is increased understanding, satisfaction with the outcome, satisfaction with the process, or something else. Integr Environ Assess Manag 2021;17:27-41. © 2020 SETAC.

QSAR Use in REACH Analyses of Alternatives to Predict Human Health and Environmental Toxicity of Alternative Chemical Substances.

In 2006, the European Union (EU) enacted the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) to address growing concerns of hazardous chemicals in the EU market. Under REACH, companies seeking authorization to use priority substances identified as substances of very high concern (SVHCs) and included in the authorization list must apply and submit health and environmental effects data in analyses of alternatives (AoAs) to the European Chemicals Agency (ECHA). To assess safer alternatives, especially in AoA hazard assessment cases where vital information could be missing or insufficient, quantitative structure-activity relationship (QSAR) nontesting methods have gained increasing acceptance and importance. This article assesses AoA applicants' use of QSAR sources and documentation while looking for meaningful trends. In this assessment, usage and frequency of QSAR sources were evaluated in 189 analyses of alternatives for 15 physicochemical properties and 19 human health and environmental endpoints to determine the scope of purpose of QSAR use in AoAs. We found that only 24 out of 189 applications cited QSAR sources to rank or evaluate the safety of their alternative substances relative to the REACH Annex XIV chemical. For human health and environmental hazard endpoints, applicants cited the Danish (Q)SAR Database (n = 63) and unidentified QSARs (n = 36) most frequently. While QSARs were not used to eliminate an alternative, 7.9% and 1.4% per maximum opportunity (MOP) of hazard endpoint and physicochemical QSAR predictions reported background information on alternatives using weight of evidence (WoE). In addition, 3.0% per MOP of hazard endpoint QSAR predictions supported the safety of the alternative while 0.7% per MOP of physicochemical QSAR predictions gave mixed support for their alternative's safety. Documentation regarding QSARs was absent in all 24 AoAs that used QSARs. Limited QSAR use and missing documentation may be the result of several factors, including inconsistent regulatory guidance. Integr Environ Assess Manag 2020;16:745-760. © 2020 SETAC.

The population prevalence of undetected abdominal aortic aneurysm in New Zealand Maori.

BACKGROUND: The prevalence of abdominal aortic aneurysm (AAA) in Polynesian populations such as the New Zealand Maori has not been characterized. We measured this in a large population-based sample. METHODS: A cross-sectional population-based prevalence study was conducted as part of an AAA screening pilot; 2467 Maori men aged 54 to 74 years and 1526 women aged 65 to 74 years registered with a primary care practice in Auckland (New Zealand) were invited to be screened by abdominal ultrasound between June 2016 and March 2018. Patients with pre-existing AAA disease and those with terminal conditions or circumstances that would make them unlikely to benefit from screening were excluded. The prevalence rate of AAA in Maori women was calculated with a cutoff definition of 27 mm as well as with the normal 30-mm definition (used in men). A log-binomial regression model estimated the prevalence rate at exactly 65 years for the purpose of comparison with screened populations in the United Kingdom. RESULTS: The crude prevalence rate of undiagnosed AAA in Maori men aged 60 to 74 years was 3.6%. In women, it was 1.7% at the 30-mm threshold and 2.3% at 27 mm. The prevalence rate at exactly 65 years of age was calculated from the log-binomial regression model to be 2.7% (confidence interval [CI], 2.0%-3.8%) in men, 0.9% (CI, 0.4%-2.2%) in women at the 30-mm threshold, and 1.5% (CI, 0.7%-3.0%) in women at the 27-mm threshold. Among smokers, the crude prevalence rates were 7.5% (CI, 4.9%-11.5%) in men and 6.9% (CI, 4.1%-11.5%) in women (30 mm+). CONCLUSIONS: The prevalence of undiagnosed AAA in New Zealand Maori men is considerably higher than in screened populations of equivalent age in the United Kingdom and Sweden. Prevalence rates in New Zealand Maori women are close to those of screened British men. New Zealand should consider implementing a population-based screening program for Maori men and conduct further research into the health impact of screening Maori women.

Multicriteria Decision Analysis Characterization of Chemical Hazard Assessment Data Sources.

Chemical hazard assessment (CHA), which aims to investigate the inherent hazard potential of chemicals, has been developed with the purpose of promoting safer consumer products. Despite the increasing use of CHA in recent years, finding adequate and reliable toxicity data required for CHA is still challenging due to issues regarding data completeness and data quality. Also, collecting data from primary toxicity reports or literature can be time consuming, which promotes the use of secondary data sources instead. In this study, we evaluate and characterize numerous secondary data sources on the basis of 5 performance attributes: reliability, adequacy, transparency, volume, and ease of use. We use GreenScreen for Safer Chemicals v1.4 as the CHA framework, which defines the endpoints of interest used in this analysis. We focused upon 34 data sources that reflect 3 types of secondary data: chemical-oriented data sources, hazard-trait-oriented data sources, and predictive data sources. To integrate and analyze the evaluation results, we applied 2 multicriteria decision analysis (MCDA) methodologies: multiattribute utility theory (MAUT) and stochastic multiobjective acceptability analysis (SMAA). Overall, the findings in this research program allow us to explore the relative importance of performance criteria and the data source quality for effectively conducting CHA. Integr Environ Assess Manag 2019;00:1-14. © 2019 SETAC.

Comparative, collaborative, and integrative risk governance for emerging technologies.

Various emerging technologies challenge existing governance processes to identify, assess, and manage risk. Though the existing risk-based paradigm has been essential for assessment of many chemical, biological, radiological, and nuclear technologies, a complementary approach may be warranted for the early-stage assessment and management challenges of high uncertainty technologies ranging from nanotechnology to synthetic biology to artificial intelligence, among many others. This paper argues for a risk governance approach that integrates quantitative experimental information alongside qualitative expert insight to characterize and balance the risks, benefits, costs, and societal implications of emerging technologies. Various articles in scholarly literature have highlighted differing points of how to address technological uncertainty, and this article builds upon such knowledge to explain how an emerging technology risk governance process should be driven by a multi-stakeholder effort, incorporate various disparate sources of information, review various endpoints and outcomes, and comparatively assess emerging technology performance against existing conventional products in a given application area. At least in the early stages of development when quantitative data for risk assessment remain incomplete or limited, such an approach can be valuable for policymakers and decision makers to evaluate the impact that such technologies may have upon human and environmental health.

Has Toxicity Testing Moved into the 21st Century? A Survey and Analysis of Perceptions in the Field of Toxicology.

BACKGROUND: Ten years ago, leaders in the field of toxicology called for a transformation of the discipline and a shift from primarily relying on traditional animal testing to incorporating advances in biotechnology and predictive methodologies into alternative testing strategies (ATS). Governmental agencies and academic and industry partners initiated programs to support such a transformation, but a decade later, the outcomes of these efforts are not well understood. OBJECTIVES: We aimed to assess the use of ATS and the perceived barriers and drivers to their adoption by toxicologists and by others working in, or closely linked with, the field of toxicology. METHODS: We surveyed 1,381 toxicologists and experts in associated fields regarding the viability and use of ATS and the perceived barriers and drivers of ATS for a range of applications. We performed ranking, hierarchical clustering, and correlation analyses of the survey data. RESULTS: Many respondents indicated that they were already using ATS, or believed that ATS were already viable approaches, for toxicological assessment of one or more end points in their primary area of interest or concern (26-86%, depending on the specific ATS/application pair). However, the proportions of respondents reporting use of ATS in the previous 12 mo were smaller (4.5-41%). Concern about regulatory acceptance was the most commonly cited factor inhibiting the adoption of ATS, and a variety of technical concerns were also cited as significant barriers to ATS viability. The factors most often cited as playing a significant role (currently or in the future) in driving the adoption of ATS were the need for expedited toxicology information, the need for reduced toxicity testing costs, demand by regulatory agencies, and ethical or moral concerns. CONCLUSIONS: Our findings indicate that the transformation of the field of toxicology is partly implemented, but significant barriers to acceptance and adoption remain. https://doi.org/10.1289/EHP1435.

Advancing Alternative Analysis: Integration of Decision Science.

BACKGROUND: Decision analysis-a systematic approach to solving complex problems-offers tools and frameworks to support decision making that are increasingly being applied to environmental challenges. Alternatives analysis is a method used in regulation and product design to identify, compare, and evaluate the safety and viability of potential substitutes for hazardous chemicals. OBJECTIVES: We assessed whether decision science may assist the alternatives analysis decision maker in comparing alternatives across a range of metrics. METHODS: A workshop was convened that included representatives from government, academia, business, and civil society and included experts in toxicology, decision science, alternatives assessment, engineering, and law and policy. Participants were divided into two groups and were prompted with targeted questions. Throughout the workshop, the groups periodically came together in plenary sessions to reflect on other groups' findings. RESULTS: We concluded that the further incorporation of decision science into alternatives analysis would advance the ability of companies and regulators to select alternatives to harmful ingredients and would also advance the science of decision analysis. CONCLUSIONS: We advance four recommendations: a) engaging the systematic development and evaluation of decision approaches and tools; b) using case studies to advance the integration of decision analysis into alternatives analysis; c) supporting transdisciplinary research; and d) supporting education and outreach efforts. https://doi.org/10.1289/EHP483.

Advancing alternatives analysis: The role of predictive toxicology in selecting safer chemical products and processes.

Alternatives analysis (AA) is a method used in regulation and product design to identify, assess, and evaluate the safety and viability of potential substitutes for hazardous chemicals. It requires toxicological data for the existing chemical and potential alternatives. Predictive toxicology uses in silico and in vitro approaches, computational models, and other tools to expedite toxicological data generation in a more cost-effective manner than traditional approaches. The present article briefly reviews the challenges associated with using predictive toxicology in regulatory AA, then presents 4 recommendations for its advancement. It recommends using case studies to advance the integration of predictive toxicology into AA, adopting a stepwise process to employing predictive toxicology in AA beginning with prioritization of chemicals of concern, leveraging existing resources to advance the integration of predictive toxicology into the practice of AA, and supporting transdisciplinary efforts. The further incorporation of predictive toxicology into AA would advance the ability of companies and regulators to select alternatives to harmful ingredients, and potentially increase the use of predictive toxicology in regulation more broadly. Integr Environ Assess Manag 2017;13:915-925. © 2017 SETAC.

Alternatives Assessment Frameworks: Research Needs for the Informed Substitution of Hazardous Chemicals.

BACKGROUND: Given increasing pressures for hazardous chemical replacement, there is growing interest in alternatives assessment to avoid substituting a toxic chemical with another of equal or greater concern. Alternatives assessment is a process for identifying, comparing, and selecting safer alternatives to chemicals of concern (including those used in materials, processes, or technologies) on the basis of their hazards, performance, and economic viability. OBJECTIVES: The purposes of this substantive review of alternatives assessment frameworks are to identify consistencies and differences in methods and to outline needs for research and collaboration to advance science policy practice. METHODS: This review compares methods used in six core components of these frameworks: hazard assessment, exposure characterization, life-cycle impacts, technical feasibility evaluation, economic feasibility assessment, and decision making. Alternatives assessment frameworks published from 1990 to 2014 were included. RESULTS: Twenty frameworks were reviewed. The frameworks were consistent in terms of general process steps, but some differences were identified in the end points addressed. Methodological gaps were identified in the exposure characterization, life-cycle assessment, and decision-analysis components. Methods for addressing data gaps remain an issue. DISCUSSION: Greater consistency in methods and evaluation metrics is needed but with sufficient flexibility to allow the process to be adapted to different decision contexts. CONCLUSION: Although alternatives assessment is becoming an important science policy field, there is a need for increased cross-disciplinary collaboration to refine methodologies in support of the informed substitution and design of safer chemicals, materials, and products. Case studies can provide concrete lessons to improve alternatives assessment.

Rural health care in New Zealand: the case of Coast to Coast Health Centre, Wellsford, an early Integrated Family Health Centre.

INTRODUCTION: Primary health care is critical, particularly in rural areas distant from secondary care services. AIM: To describe the development of Coast to Coast Health Centre (CTCHC) at Wellsford, north of Auckland, New Zealand and reflect on its achievements and ongoing challenges. METHODS: Interviews were conducted with staff and management of CTCHC and with other health service providers. Surveys of staff and a sample of enrolled patients were undertaken. Numerical data on service utilisation were obtained from the practice and from national datasets. RESULTS: The CTCHC provides a wide range of services, including after-hours care, maternity and radiology, across a network of electronically connected sites, as well as interdisciplinary training for a range of health students. General practitioner (GP) recruitment is problematic and nursing roles have been expanded. Staff report positively on the work environment. Consultation rates are higher than in comparable practices, especially consultations with nurses. Rates of hospital admission are relatively low. The development of the CTCHC was assisted by formation of a local primary health organisation (PHO) and by recognition by the local district health board (DHB). Issues with poor coordination of local services, and less service provision than is characteristic in urban areas, remain. Contracting processes with the DHB were complex and time-consuming. The merging of the local PHO into a larger PHO within the Waitemata DHB catchment inhibited progression towards more complete locality planning. DISCUSSION: A dedicated and locally controlled provider was able to generate a more than usually complete community health service for Wellsford and area.

Decisions, Science, and Values: Crafting Regulatory Alternatives Analysis.

Emerging "prevention-based" approaches to chemical regulation seek to minimize the use of toxic chemicals by mandating or directly incentivizing the adoption of viable safer alternative chemicals or processes. California and Maine are beginning to implement such programs, requiring manufacturers of consumer products containing certain chemicals of concern to identify and evaluate potential safer alternatives. In the European Union, the REACH program imposes similar obligations on manufacturers of certain substances of very high concern. Effective prevention-based regulation requires regulatory alternatives analysis (RAA), a methodology for comparing and evaluating the regulated chemical or process and its alternatives across a range of relevant criteria. RAA has both public and private dimensions. To a significant degree, alternatives analysis is an aspect of product design; that is, the process by which private industry designs the goods it sells. Accordingly, an RAA method should reflect the attributes of well-crafted product design tools used by businesses. But RAA adds health and environmental objectives to the mix of concerns taken into account by the product designer. Moreover, as part of a prevention-based regulatory regime, it implicates important public values such as legitimacy, equity, public engagement, and accountability. Thus, an RAA should reflect both private standards and public values, and be evaluated against them. This article adopts that perspective, identifying an integrated set of design principles for RAA, and illustrating the application of those principles.

Nanomaterial categorization for assessing risk potential to facilitate regulatory decision-making.

For nanotechnology to meet its potential as a game-changing and sustainable technology, it is important to ensure that the engineered nanomaterials and nanoenabled products that gain entry to the marketplace are safe and effective. Tools and methods are needed for regulatory purposes to allow rapid material categorization according to human health and environmental risk potential, so that materials of high concern can be targeted for additional scrutiny, while material categories that pose the least risk can receive expedited review. Using carbon nanotubes as an example, we discuss how data from alternative testing strategies can be used to facilitate engineered nanomaterial categorization according to risk potential and how such an approach could facilitate regulatory decision-making in the future.

A multi-stakeholder perspective on the use of alternative test strategies for nanomaterial safety assessment.

There has been a conceptual shift in toxicological studies from describing what happens to explaining how the adverse outcome occurs, thereby enabling a deeper and improved understanding of how biomolecular and mechanistic profiling can inform hazard identification and improve risk assessment. Compared to traditional toxicology methods, which have a heavy reliance on animals, new approaches to generate toxicological data are becoming available for the safety assessment of chemicals, including high-throughput and high-content screening (HTS, HCS). With the emergence of nanotechnology, the exponential increase in the total number of engineered nanomaterials (ENMs) in research, development, and commercialization requires a robust scientific approach to screen ENM safety in humans and the environment rapidly and efficiently. Spurred by the developments in chemical testing, a promising new toxicological paradigm for ENMs is to use alternative test strategies (ATS), which reduce reliance on animal testing through the use of in vitro and in silico methods such as HTS, HCS, and computational modeling. Furthermore, this allows for the comparative analysis of large numbers of ENMs simultaneously and for hazard assessment at various stages of the product development process and overall life cycle. Using carbon nanotubes as a case study, a workshop bringing together national and international leaders from government, industry, and academia was convened at the University of California, Los Angeles, to discuss the utility of ATS for decision-making analyses of ENMs. After lively discussions, a short list of generally shared viewpoints on this topic was generated, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis.